Page 222 - 2014 Printable Abstract Book
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higher number was mainly due to increases in categories D and E Dcx+ neurons. Consistent with this
finding, the number of BrdU+/NeuN+ neurons, both in total number and as % BrdU+ cells, was also higher
in MnBuOE treated group. Furthermore, no overt physiological changes or tissue abnormalities were
observed in MnBuOE-treated mice at the end of the two-week treatment. The study results suggest that
long-term MnBuOE treatment can be safely administered to protect hippocampal neurogenesis during
and after cranial irradiation.
(PS3-58) Implementation of good laboratory practice for radiation countermeasure screening in an
academic setting. Isabel L. Jackson; Emily Swanson; Sue Messics; Michelle Padget; and Zeljko Vujaskovic
University of Maryland School of Medicine, Baltimore, MD
Objective: We have previously developed small animal models of delayed radiation toxicity that
are now used to perform medical countermeasure (MCM) efficacy screens consistent with the
requirements of the FDA Animal Rule for industry and government sponsors. As a part of MCM approval
through the FDA-AR, pivotal efficacy studies are expected to be conducted in compliance with Good
Laboratory Practice (GLP) regulations. The objective here was to successfully implement a GLP program
within an academic environment to meet the FDA requirements for pivotal efficacy studies.
Methods: In order to establish a GLP program within a small animal laboratory we first developed a GLP
implementation plan with our QAU followed by establishment of a clear laboratory infrastructure. We
then developed appropriate Standard Operating Procedures (SOPs), data collection forms, and
standardized training practices for animal work as well as laboratory and equipment use and
maintenance. We are in the process of performing validation of our major and minor equipment according
to our equipment validation plan. Results: Initial audits conducted by an independent Quality Assurance
unit have revealed excellent progress towards GLP compliance. New methods for study organization and
quality control have significantly improved raw data integrity. In addition, we found the time required for
GLP development in the laboratory was significantly reduced as we benefited from using previously
established administrative, protocol, IT, and facility SOPs, Part 11 compliant data documentation and IT
programs including secured database servers for data storage. Conclusions: Implementation of GLP in an
academic environment is feasible with superior institutional support. Major obstacles encountered were
the demands on cost and time due to hiring of QA and other personnel, purchasing Part 11 compliant
software, and equipment validation. GLP implementation is not as difficult or restrictive as it may
commonly be viewed in academia. It is not only possible, but extremely advantageous for ensuring data
quality and reproducibility. As a result, the laboratory is moving forward with conducting all studies,
including basic science research, as GLP “like”. Most importantly, we have found GLP is a culture of quality
to be embraced rather than feared.
(PS3-60) Study of adaptive response induced by different dose rates of gamma radiation in TK6 and
MCF-10 cells. Sara Shakeri Manesh, Stockholm University, Stockholm, Sweden
A phenomenon in which exposure to a low priming dose of gamma radiation or any other
clastogenic agent makes cells more resistant to the effects of a subsequent high dose exposure is termed
adaptive response. Radiation-induced adaptive response could hypothetically reduce the risk of late
adverse effects for humans, in response to chronic or acute exposures to radiation, and understanding
220 | P a g e
finding, the number of BrdU+/NeuN+ neurons, both in total number and as % BrdU+ cells, was also higher
in MnBuOE treated group. Furthermore, no overt physiological changes or tissue abnormalities were
observed in MnBuOE-treated mice at the end of the two-week treatment. The study results suggest that
long-term MnBuOE treatment can be safely administered to protect hippocampal neurogenesis during
and after cranial irradiation.
(PS3-58) Implementation of good laboratory practice for radiation countermeasure screening in an
academic setting. Isabel L. Jackson; Emily Swanson; Sue Messics; Michelle Padget; and Zeljko Vujaskovic
University of Maryland School of Medicine, Baltimore, MD
Objective: We have previously developed small animal models of delayed radiation toxicity that
are now used to perform medical countermeasure (MCM) efficacy screens consistent with the
requirements of the FDA Animal Rule for industry and government sponsors. As a part of MCM approval
through the FDA-AR, pivotal efficacy studies are expected to be conducted in compliance with Good
Laboratory Practice (GLP) regulations. The objective here was to successfully implement a GLP program
within an academic environment to meet the FDA requirements for pivotal efficacy studies.
Methods: In order to establish a GLP program within a small animal laboratory we first developed a GLP
implementation plan with our QAU followed by establishment of a clear laboratory infrastructure. We
then developed appropriate Standard Operating Procedures (SOPs), data collection forms, and
standardized training practices for animal work as well as laboratory and equipment use and
maintenance. We are in the process of performing validation of our major and minor equipment according
to our equipment validation plan. Results: Initial audits conducted by an independent Quality Assurance
unit have revealed excellent progress towards GLP compliance. New methods for study organization and
quality control have significantly improved raw data integrity. In addition, we found the time required for
GLP development in the laboratory was significantly reduced as we benefited from using previously
established administrative, protocol, IT, and facility SOPs, Part 11 compliant data documentation and IT
programs including secured database servers for data storage. Conclusions: Implementation of GLP in an
academic environment is feasible with superior institutional support. Major obstacles encountered were
the demands on cost and time due to hiring of QA and other personnel, purchasing Part 11 compliant
software, and equipment validation. GLP implementation is not as difficult or restrictive as it may
commonly be viewed in academia. It is not only possible, but extremely advantageous for ensuring data
quality and reproducibility. As a result, the laboratory is moving forward with conducting all studies,
including basic science research, as GLP “like”. Most importantly, we have found GLP is a culture of quality
to be embraced rather than feared.
(PS3-60) Study of adaptive response induced by different dose rates of gamma radiation in TK6 and
MCF-10 cells. Sara Shakeri Manesh, Stockholm University, Stockholm, Sweden
A phenomenon in which exposure to a low priming dose of gamma radiation or any other
clastogenic agent makes cells more resistant to the effects of a subsequent high dose exposure is termed
adaptive response. Radiation-induced adaptive response could hypothetically reduce the risk of late
adverse effects for humans, in response to chronic or acute exposures to radiation, and understanding
220 | P a g e
